Based on the excellent clinical benefits and durable response achieved by nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients suffering from unresectable HER2-negative GC, GEJC, and EAC, the FDA approved this therapy in April 2021 for first-line treatment of tumors with CPS ≥5 (category 1) and CPS <5 under certain circumstances (category 2B) (49). The gene discussed is ERBB2; the disease is gastric cancer.